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SANDOZ RIVASTIGMINE is a brand name for Rivastigmine, supplied as a patch. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: SANDOZ RIVASTIGMINE PATCH (rivastigmine transdermal patch) is indicated for: The symptomatic treatment of patients with mild to moderately severe dementia of the Alzheimer's type. Rivastigmine patches have not been studied in controlled clinical trials for longer than 6 months. SANDOZ RIVASTIGMINE PATCH should only…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Exposure to sources of heat may increase a drug’s ability to penetrate the skin when administered to a patient by transdermal patch and this may result in increased drug exposure. The applied patch area should not be exposed to, or have direct contact with, external heat sources such as excessive sunlight, heat lamps, heating pads, saunas, hot tubs, etc.
This may also occur if the patient has a fever. Patients and caregivers should be advised that the patch area should not be exposed to external heat sources while wearing rivastigmine patches. Hepatic Impairment: Rivastigmine patches have not been studied in hepatic impairment.
Due to increased exposure in mild to moderate hepatic impairment, as observed with the oral formulation, dosing recommendations to titrate according to individual tolerability should be closely followed. Patients with clinically significant hepatic impairment may experience more adverse events.
Caution should be used when titrating hepatically impaired patients (see 10 CLINICAL PHARMACOLOGY). Renal Impairment: Rivastigmine patches have not been studied in renal impairment. Dose titration for patients with renal impairment should be undertaken with caution (see 10 CLINICAL PHARMACOLOGY).
g. below 50 kg), as they may experience more adverse reactions. g. excessive nausea or vomiting) and consider reducing the dose if such adverse reactions develop. Dose escalation for patients with serious comorbid diseases should be undertaken with particular caution.
In a population of cognitively-impaired individuals, the correct and safe use of this and all other medications may require supervision (see 7 WARNINGS AND PRECAUTIONS, Patient and Caregiver Counselling Information). g. hypertension and hallucinations and worsening of extrapyramidal symptoms) in patients with Alzheimer’s dementia have been observed shortly after dose increase.
They may respond to a dose reduction or discontinuation. 2 Recommended Dose and Dosage Adjustment SANDOZ RIVASTIGMINE PATCH should only be prescribed by (or following consultation with) clinicians who are experienced in the diagnosis and management of Alzheimer’s disease.
5 mg SANDOZ RIVASTIGMINE PATCH (Rivastigmine Hydrogen Tartrate) Page 6 of 58 Patches Rivastigmine base dose load† Rivastigmine base in vivo release rates per 24 h‡ PATCH 10 † Drug content of the patch ‡ Quantity of drug released over a 24-h patch application time interval Initial dose: Treatment is started with SANDOZ RIVASTIGMINE PATCH 5 applied once a day.
, Skin irritation). The same skin location should not be used within 14 days. Important administration instructions (patients and caregivers should be instructed accordingly (see 7 WARNINGS AND PRECAUTIONS, Patient and Caregiver Counselling Information; PATIENT MEDICATION INFORMATION) Only one patch should be worn at a time (see 7 WARNINGS AND PRECAUTIONS and 5 OVERDOSAGE, Symptoms).
The previous day’s patch must be removed before applying a new one. The patch should be replaced by a new one after 24 hours. The patch should not be applied to skin that is red, irritated or cut. , another spot on the upper back).
The patch should be pressed down firmly by applying pressure with the hand over the entire patch for at least 30 seconds, making sure that the edges stick well. If the patch falls off, a new one should be applied for the rest of the day, then it should be replaced at the same time as usual the next day.
The patch can be used in everyday situations, including bathing and during hot weather however, it should be checked to ensure it has remained well adhered. Showering and washing the patch site is possible without loss of adherence.
To ensure proper adherence, the patch should not be applied to wet or damp skin. g. excessive sunlight, saunas, solarium) for long periods of time. The patch should not be cut into pieces. Wash your hands with soap and water after removing the patch.
In case of contact with eyes or if the eyes become red after handling the patch, rinse immediately with plenty of water and seek medical advice if symptoms do not resolve.
Incompatibilities:
To prevent interference with the adhesive properties of the patch, the patch should not be applied to a skin area where cream, lotion or powder has recently been applied. 5 Missed Dose The missed dose should be taken immediately or at the next scheduled dose.
, Cardiovascular 11/2023 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ............................................................................................ 2 TABLE OF CONTENTS..............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ...................................................................... 4 1 INDICATIONS ..............................................................................................................
1 Pediatrics ................................................................................................................... 2 Geriatrics ...................................................................................................................
4 2 CONTRAINDICATIONS ................................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX............................................................. 4 4 DOSAGE AND ADMINISTRATION .................................................................................
1 Dosing Considerations............................................................................................... 2 Recommended Dose and Dosage Adjustment ......................................................... 4 Administration...........................................................................................................
5 Missed Dose .............................................................................................................. 7 5 OVERDOSAGE .............................................................................................................
7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.................................. 9 7 WARNINGS AND PRECAUTIONS ................................................................................ 1 Special Populations .................................................................................................
11/2023 7 WARNINGS AND PRECAUTIONS, Cardiovascular 11/2023 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ............................................................................................ 2 TABLE OF CONTENTS..............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ...................................................................... 4 1 INDICATIONS ..............................................................................................................
1 Pediatrics ................................................................................................................... 2 Geriatrics ...................................................................................................................
4 2 CONTRAINDICATIONS ................................................................................................. 4
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Replace with a new patch every 24 hours.
Dose titration:
Increase the daily dose by increasing the patch size, only after a minimum of 4 weeks at the previous dose, and only if the previous dose has been well tolerated. Continue the recommended dose of SANDOZ RIVASTIGMINE PATCH 10 for as long as therapeutic benefit persists.
The clinical benefit of rivastigmine should be reassessed on a regular basis. Discontinuation should also be considered when evidence of a therapeutic effect at the optimal dose is no longer present.
Interruption of treatment:
Treatment should be temporarily interrupted if gastrointestinal adverse effects are observed, until these adverse effects resolve. Patch treatment can be resumed at the same dose if treatment is not interrupted for more than three days.
Otherwise, treatment should be reinitiated with SANDOZ RIVASTIGMINE PATCH 5. If adverse effects persist on re-initiation of therapy, the dose should be temporarily reduced to SANDOZ RIVASTIGMINE PATCH 5.
Hepatic impairment:
Rivastigmine patches have not been studied in patients with hepatic impairment. Caution should be used when dosing hepatically impaired patients according to individual tolerability and these patients should be closely monitored. (see 10 CLINICAL PHARMACOLOGY) Renal Impairment: No dose adjustment is necessary for patients with renal impairment.
Switching from Capsules or Oral Solution:
Patients treated with rivastigmine capsules or oral solution may be switched to rivastigmine patches as follows: A patient who is on a dose of < 3 mg BID (<6 mg/ day) oral rivastigmine can be switched to SANDOZ RIVASTIGMINE PATCH 5.
A patient who is on a dose of 3 to 6 mg BID (6 to 12 mg/ day) oral rivastigmine may be directly switched to SANDOZ RIVASTIGMINE PATCH 10. It is recommended to apply the first patch on the day following the last oral dose. 4 Administration rivastigmine patches should be applied once a day to clean, dry, hairless, intact healthy skin on the upper or lower back, upper arm, or chest, in a place that will not be rubbed by tight clothing.
Application of the patch to other areas, such as the abdomen and thighs, has been shown to decrease the bioavailability of rivastigmine and cause more skin irritation (see 10 SANDOZ RIVASTIGMINE PATCH (Rivastigmine Hydrogen Tartrate) Page 7 of 58 CLINICAL PHARMACOLOGY, Pharmacokinetics; 8 ADVERSE REACTIONS, Skin irritation).
The same skin location should not be used within 14 days. Important administration instructions (patients and caregivers should be instructed accordingly (see 7 WARNINGS AND PRECAUTIONS, Patient and Caregiver Counselling Information; PATIENT MEDICATION INFORMATION) Only one patch should be worn at a time (see 7 WARNINGS AND PRECAUTIONS and
Doses should not be doubled. Following initiation of therapy or any dosage increase, patients should be closely monitored for adverse effects. g. nausea, vomiting, abdominal pain, loss of appetite) are observed during treatment, the patient should be instructed to stop treatment and then restart at the same dose level, or lower, as clinically indicated.
If therapy has been interrupted for three days, treatment should be reinitiated with SANDOZ RIVASTIGMINE PATCH 5. If side effects persist, the drug should be discontinued (see 7 WARNINGS AND PRECAUTIONS). 5 OVERDOSAGE Symptoms: Manifestations include nausea, vomiting, diarrhea, abdominal pain, dizziness, SANDOZ RIVASTIGMINE PATCH (Rivastigmine Hydrogen Tartrate) Page 8 of 58 tremor, headache, somnolence, bradycardia, confusional state, hyperhidrosis, hypertension, hallucinations and malaise.
Overdosage with cholinesterase inhibitors can result in cholinergic crisis characterised by severe nausea, vomiting, salivation, sweating, bradycardia, hypotension, respiratory depression, collapse and convulsions. Increasing muscle weakness is a possibility and may result in death if respiratory muscles are involved.
Atypical responses in blood pressure and heart rate have been reported with other cholinomimetics when co-administered with quaternary anticholinergics such as glycopyrrolate. Due to the known vagotonic effect of cholinesterase inhibitors on heart rate, bradycardia and/or syncope may also occur.
In a documented case of a 46 mg overdose with rivastigmine capsules, a 69 year old female patient experienced vomiting, incontinence, hypertension, psychomotor retardation and loss of consciousness. The patient was managed conservatively with only supportive measures and fully recovered within 24 hours.
5 mg/24hrs) per day was accidentally administered 6 patches per day on two consecutive days. The patient experienced vomiting, fall and hyperhidrosis and was hospitalized on the second day. At the time of hospitalization, he presented with an elevated creatinine level (149 μmol/L; normal range: 70-115 μmol/L) and signs of urinary infection.
He was treated by removal of all patches and ciprofloxacin was initiated. Subsequently, the patient developed acute renal failure with anuria and died approximately 14 days after hospitalization. The reporter suspected that overdose contributed to the patient's dehydration and renal failure.
Autopsy results were not provided by the reporter. Dose-related signs of toxicity in animals included lacrimation, excessive salivation, vomiting, decreased locomotor activity, ataxia, twitches/flutters, tremors and clonic convulsions.
Overdose with rivastigmine patches resulting from misuse/medication errors (application of multiple patches at a time) has been reported in the post-marketing setting (see 7 WARNINGS AND PRECAUTIONS; 8 ADVERSE REACTIONS, Post-Market Adverse Reactions).
The typical symptoms reported among these cases are similar to those seen with cases of overdose associated with rivastigmine oral formulations. 4 hours after patch administration and a duration of acetylcholinesterase inhibition of about 9 hours, it is recommended that in cases of asymptomatic overdose the patch should be immediately removed, and no further patch should be applied for the next 24 hours.
In overdoses accompanied by severe nausea and vomiting, the use of antiemetics should be considered. Symptomatic treatment for other adverse events should also be given as necessary. Tertiary anticholinergics such as atropine may be used as an antidote for rivastigmine overdosage.
Intravenous atropine sulfate […]
1 Pregnant Women .............................................................................................. 2 Breast-feeding ................................................................................................... 3 Pediatrics ...........................................................................................................
4 Geriatrics ........................................................................................................... 17 8 ADVERSE REACTIONS ................................................................................................
1 Adverse Reaction Overview .................................................................................... 2 Clinical Trial Adverse Reactions............................................................................... 3 Less Common Clinical Trial Adverse Reactions .......................................................
5 Post-Market Adverse Reactions .............................................................................. 24 SANDOZ RIVASTIGMINE PATCH (Rivastigmine Hydrogen Tartrate) Page 3 of 58 9 DRUG INTERACTIONS................................................................................................
2 Drug Interactions Overview .................................................................................... 3 Drug-Behavioural Interactions ................................................................................ 4 Drug-Drug Interactions............................................................................................
5 Drug-Food Interactions ........................................................................................... 6 Drug-Herb Interactions ...........................................................................................
7 Drug-Laboratory Test Interactions .......................................................................... 27 10 CLINICAL PHARMACOLOGY ....................................................................................... 1 Mechanism of Action ........................................................................................
2 Pharmacodynamics ........................................................................................... 3 Pharmacokinetics .............................................................................................. 28 11 STORAGE, STABILITY AND DISPOSAL .........................................................................
32 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 32 PART II: SCIENTIFIC INFORMATION.......................................................................................
33 13 PHARMACEUTICAL INFORMATION ............................................................................ 33 14 CLINICAL TRIALS........................................................................................................
1 Efficacy and Safety Studies................................................................................ 2 Study Results ..................................................................................................... 35 15 MICROBIOLOGY ........................................................................................................
37 16 NON-CLINICAL TOXICOLOGY ..................................................................................... 37 PATIENT MEDICATION INFORMATION.................................................................................. 45 SANDOZ RIVASTIGMINE PATCH (Rivastigmine Hydrogen Tartrate) Page 4 of 58 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS SANDOZ RIVASTIGMINE PATCH (rivastigmine transdermal patch) is indicated for: The symptomatic treatment of patients with mild to moderately severe dementia of the […]